Registration Dossier
Registration Dossier
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EC number: 234-974-5 | CAS number: 12047-11-9
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure
Data source
Materials and methods
Results and discussion
Results (fetuses)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to column 2 of REACH Annexes on standard information requirements, the developmental toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance. Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure. In light of above issues, no developmental toxicity test has been carried out and no testing is proposed at the present.
- Executive summary:
According to column 2 of REACH Annexes on standard information requirements, the developmental toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance. Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure. In light of above issues, no developmental toxicity test has been carried out and no testing is proposed at the present.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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